March 11, 2025

The need-to-know this morning

Viking Therapeutics signed a contract manufacturer to make its experimental treatment for obesity, but the deal also signals the company isn't being acquired any time soon, as many investors had hoped.

oncology

Protein degrader shows mixed results in breast cancer study

An experimental drug developed by the biotech firm Arvinas and Pfizer — the first in a class of medicines based on a cell's natural machinery for eliminating diseased proteins — delayed tumor progression in women with a genetically altered form of the most common type of breast cancer, the companies said this morning.

In the Phase 3 study, the drug called vepdegestrant achieved the primary efficacy goal in participants with ER-positive, HER2-negative metastatic breast cancer rendered more difficult to treat due to a genetic mutation called ESR1. However, vepdegestrant was not effective in a larger group of participants with breast cancer lacking the ESR1 mutation.

M&A

Bristol buys out cancer cell therapy partner

Bristol Myers Squibb said it will acquire its struggling CAR-T partner 2Seventy Bio for $286 million, or $102 million net of estimated cash. The deal values 2Seventy at $5 per share, an 88% premium to Monday's closing stock price.

By acquiring 2Seventy Bio, Bristol eliminates its obligation to pay royalties on sales of Abecma, a personalized CAR-T therapy for multiple myeloma.

2Seventy was once part of cell and gene therapy maker Bluebird Bio. The two companies split in 2021 amid financial and clinical setbacks. Independence didn't improve 2Seventy's outlook. Despite securing the approval of Abecma, which is marketed by Bristol, the company failed to develop additional cancer therapies and eventually culled its entire R&D operation.

Last month, Bluebird also ceased to exist as a publicly traded company, following its sale to private equity investors.

markets

Biotech's strong news day wasn't enough to support the XBI

It's been a long time since we experienced such a positive biotech news day like yesterday:

Beam Therapeutics's CRISPR treatment showed encouraging results in a debilitating lung condition. Mineralys Therapeutics said that its experimental drug significantly reduced blood pressure in two different studies. Protagonist Therapeutics reported positive results of the drug it's developing with Johnson & Johnson in ulcerative colitis. And Checkpoint Therapeutics, a cancer immunotherapy company, said it would be acquired by Sun Pharma at a 66% premium to its previous closing price.

You'd think this amount of good news, and stock moves for the individual companies (Protagonist surged 46% yesterday), would at least offer the XBI temporary reprieve from its prolonged slump. Yet the industry was still weighed down by the broader market.

vTFET-biotech-s-good-news-day-weighed-down-by-broader-market

U.S. stocks saw their biggest drop of the year yesterday, with the SPY falling 2.6%, as President Trump declined to rule out a recession as a potential result of his economics policies. The XBI outperformed the SPY, but still fell 1.2%.

politics

FDA blocks reviewers, inspectors from buyout offer

Yesterday, we brought you the news that HHS sent a buyout offer to workers across its departments, including the FDA, CDC, and NIH.

Endpoints News reported that the FDA told staff that reviewers of drugs and medical devices and inspectors of manufacturing facilities cannot take the buyout offer. Many of these staff are funded by user fees paid by drug and device sponsors to ensure the timely review of their products.

This is the latest in a turbulent series of developments for FDA staff. Last month, the Trump administration fired FDA employees as part of a government-wide cost-cutting effort overseen by DOGE, but then rehired some of the workers days later.

Health tech

Telehealth companies pivot from GLP-1s to hormones

As branded GLP-1 drugs fell into shortage over the last two years, hundreds of telehealth companies popped up to prescribe compounded copies. But as branded GLP-1 drugs come back into supply, threatening the business of compounded copies, dozens of telehealth companies are now shifting to offer hormone replacement therapies.

Noom, best known for its weight loss app and more recent GLP-1 offering, launched a hormone therapy program for menopause in late February, and telehealth company Hims & Hers plans to roll out at-home testing over the next year to enable care for low testosterone, perimenopause, and menopause.

Patients have long advocated for better access to hormone-based care. But clinicians and health policy researchers are concerned that the commodification of hormone therapies — often marketed as a personalized fix for low energy, libido, and other age-related concerns — could lead to inappropriate prescriptions and put patients at risk.

pharma

How well can a pharma trade group regulate its members?

The Association of British Pharmaceutical Industry, a U.K. trade group that sets industry code, is due to lift a rare suspension it imposed on Novo Nordisk for "serious breaches" in promoting an obesity drug.

Has Novo learned its lesson, though? Since the suspension, the company again breached various codes for infractions such as promoting an obesity drug to the public through sponsorships at pharmacy chains and failing to disclose substantial payments to health and patient groups.

Given that, academics question whether the public should feel reassured by the industry group that Novo has substantively changed its business practices and that the group is properly enforcing its own rules.

obesity

Investors yet again disappointed by Novo data

And speaking of Novo — the Danish company's shares plunged again yesterday, as investors were disappointed by new data of the next-gen obesity drug CagriSema in patients with diabetes.

In a late-stage trial of people with obesity and type 2 diabetes, patients on CagriSema lost 13.7% of their weight over 68 weeks when looking at all participants, including those who dropped out.

Investors were expecting greater weight loss, particularly since an earlier mid-stage trial of CagriSema showed that patients with obesity and diabetes lost 15.6% of their weight over a period of just 32 weeks. In this new late-stage trial, though, Novo incorporated a flexible dosing protocol, meaning it allowed patients to modify their dosing rather than stay on the highest dose.